Scoliosis IdiopathicVRAS-PSNCT04584970
Virtual Reality After Pediatric Scoliosis Surgery
A study testing Applied VR and Apple iPad in people with Scoliosis Idiopathic and Pain, Postoperative, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the use of virtual reality after scoliosis surgery in pediatric patients. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Scoliosis Idiopathic, Pain, Postoperative
- What is being tested?
- Applied VR and Apple iPad
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2020to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects age 11 - 17 years of age
- Patients undergoing idiopathic scoliosis surgery on Enhanced Recovery after Surgery (ERAS) spine protocol (which includes postoperative PCA)
Who cannot join
- Patient/caregiver refusal
- Patients with developmental delay
- Patients with seizure disorder
- Non-English-speaking patients
- Patients with daily opioid use >/= two weeks
- Patients with uncorrected visual or hearing impairment
- Patients admitted to pediatric intensive care unit on postoperative day #1
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina (UNC) Hospitals
Chapel Hill, North Carolina, 27599
About this study
Official title: Evaluation of Virtual Reality Intervention After Pediatric Idiopathic Scoliosis Surgery to Reduce Postoperative Pain and Opioid Consumption
The purpose of this study is to evaluate the use of virtual reality after scoliosis surgery in pediatric patients.
Read the detailed description
Purpose: To evaluate postoperative pain scores and postoperative opioid use in pediatric idiopathic scoliosis surgical patients using virtual reality (VR) as a method of immersive distraction compared with standard electronic use postoperatively.
Participants: Patients age 11-17 undergoing idiopathic scoliosis surgery on Enhanced Recovery After Surgery (ERAS) spine protocol at our institution.
Procedures (methods): Participants will be randomized to intervention arm (VR) or control arm (iPad). Baseline pain and anxiety scores will be assessed. On postoperative day 1, each patient will receive a visit by the research assistant who will assess pain scores, PCA use, etc. The intervention group will be offered a VR device for up to 30 minutes. The control group will be offered an iPad for up to 30 minutes. This visit will be performed twice on postoperative day 1. Follow up survey will be conducted at 48-72 hours and 7-10 days postoperatively.
- Conditions
- Scoliosis Idiopathic, Pain, Postoperative
- Being tested
- Applied VR, Apple iPad
- Keywords
- Virtual reality, Distraction methods, Idiopathic scoliosis, Postoperative pain, Pediatric surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Applied VRDevice
The Applied VR device is a lightweight mobile virtual reality headset with embedded software, creating an immersive experience. The Applied VR is specifically designed for medical use.
Apple iPadDevice
The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality device | Experimental | Participants will be offered a virtual reality (VR) device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Receives: Device: Applied VR |
| iPad device | Active comparator | Participants will be offered an iPad device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. Receives: Device: Apple iPad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores Via FACES Scale by Patient at Baseline
All patients will be oriented to the Wong-Baker FACES Pain Rating scale preoperatively. This is a self-assessment scale; patients select a face that illustrates the pain they are experiencing. Scores 0-10, with 0=No hurt and 10=Hurts worst. Higher score indicates a worse outcome.
Measured: Recorded preoperatively as baseline
Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=0
All patients will be oriented to the Wong-Baker FACES Pain Rating scale preoperatively. This is a self-assessment scale; patients select a face that illustrates the pain they are experiencing. Scores 0-10, with 0=No hurt and 10=Hurts worst. Higher score indicates a worse outcome. Assessed immediately prior to first intervention exposure (T=0 min) during 1 30-minute session on day 1 postoperatively.
Measured: Recorded immediately prior to intervention (T=0 min)
Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=30
All patients will be oriented to the Wong-Baker FACES Pain Rating scale preoperatively. This is a self-assessment scale; patients select a face that illustrates the pain they are experiencing. Scores 0-10, with 0=No hurt and 10=Hurts worst. Higher score indicates a worse outcome. Assessed immediately after first intervention exposure (T=30 min) following 1 30-minute session on day 1 postoperatively.
Measured: Recorded at end of intervention (T=30 minutes)
Pain Scores Via FLACC Scale by Research Assistant at Baseline
The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome.
Measured: Recorded preoperatively as baseline
Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=0
The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome. Assessed immediately prior to first intervention exposure (T=0 min) during 1 30-minute session on day 1 postoperatively.
Measured: Recorded immediately prior to intervention (T=0 minutes)
Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=10
The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome. Assessed immediately during first intervention exposure (T=10 min) during 1 30-minute session on day 1 postoperatively.
Measured: Recorded at the 10 minute mark (T=10 minutes)
Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=30
The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome. Participants were allowed to play/interact with intervention for up to 30 minutes. Assessed immediately following first intervention exposure (T=30 min) following 1 30-minute session on day 1 postoperatively.
Measured: Recorded at end of intervention (T=30 minutes)
Opioid PCA Use at T=-60-0
Opioid use via Patient-Controlled Analgesia (PCA) pump in mcg or mg as appropriate. PCA use will be converted to morphine equivalents at time of data entry. A higher number indicates more opioid used during the time interval. Higher number indicates a worse outcome.
Measured: Recorded for the hour prior to intervention (T=-60-0 minutes)
Opioid PCA Use at T=0-30
Opioid use via PCA pump in mcg or mg as appropriate. PCA use will be converted to morphine equivalents at time of data entry. A higher number indicates more opioid used during the time interval. Higher number indicates a worse outcome.
Measured: Recorded during intervention (T=0-30 minutes)
Opioid PCA Use at T=30-90
Opioid use via PCA pump in mcg or mg as appropriate. PCA use will be converted to morphine equivalents at time of data entry. A higher number indicates more opioid used during the time interval. Higher number indicates a worse outcome.
Measured: Recorded one hour after intervention is complete (T=30-90 minutes)
Total Opioid Dose (in Milligram Morphine Equivalents)
The amount of opioids used by the patient will be recorded in all subjects and converted into milligram morphine equivalents based on chart reviews. This collection method was added to replace PCA pump usage unavailability.
Measured: From anesthesia end through hospital discharge, a total of approximately 2 days
Secondary outcomes (8)
Electronic Device Use
VR device or iPad use in minutes. Minimal 0 minutes, maximum 60 minutes (30 minutes x 2 sessions). A higher number indicates more electronic device use, which is neither a better or worse outcome, but rather provides information about whether devices were used for the full allotted time or not.
Measured: Assessed at time of intervention on postoperative day #1
Baseline Anxiety Score Via STAI Short Form Baseline Anxiety Score Via STAI Short Form
The State-Trait Anxiety Inventory (STAI) Short Form scoring tool is a self-report questionnaire. It contains 6 statements (i.e., 'I feel calm', with 1=Not at all, 2=Somewhat, 3=Moderately, 4=Very much). Scores range from 6-24, with 6 signifying no anxiety and 24 points signifying the highest level of anxiety. Higher score indicates a worse outcome.
Measured: Recorded preoperatively as baseline
Postoperative Behavioral Changes Via PHBQ-AS Form at 48-72 Hours
A follow up survey will be given using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS) form via a phone call, email or in person from a member of the research team. There are 11 items on a five-point scale (i.e., 1=Much less than before, 5=Much more than before). Total scores 11-55, with higher scores indicating more negative behavioral changes. Higher score indicates a worse outcome.
Measured: At approximately 48-72 hours postoperatively
Postoperative Behavioral Changes Via PHBQ-AS Form at 7-10 Days
A follow up survey will be given using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS) form via a phone call, email or in person from a member of the research team. There are 11 items on a five-point scale (i.e., 1=Much less than before, 5=Much more than before). Total scores 11-55, with higher scores indicating more negative behavioral changes. Higher score indicates a worse outcome.
Measured: At approximately 7-10 days postoperatively
Patient Satisfaction at 48-72 Hours
To assess patient satisfaction, qualitative satisfaction will be documented. Patient satisfaction and overall experience are commonly linked to pain experienced during a hospitalization, and as a result, satisfaction with the use of VR as a method of pain control will be one of the outcomes. Patients will simply be asked by the researcher assistant, qualitatively, how satisfied they were with their experience with the device, and their comments will be recorded. Collected answers will be divided into positive and negative comments, and any emerging themes will be identified.
Measured: At approximately 48-72 hours postoperatively
Patient Satisfaction at 7-10 Days
To assess patient satisfaction, qualitative satisfaction will be documented. Patient satisfaction and overall experience are commonly linked to pain experienced during a hospitalization, and as a result, satisfaction with the use of VR as a method of pain control will be one of the outcomes. Patients will simply be asked by the researcher assistant, qualitatively, how satisfied they were with their experience with the device, and their comments will be recorded. Collected answers will be divided into positive and negative comments, and any emerging themes will be identified.
Measured: At approximately 7-10 days postoperatively
Caregiver Satisfaction at 48-72 Hours
To assess caregiver satisfaction, qualitative satisfaction will be documented. Patient and caregiver satisfaction and overall experience are commonly linked to pain experienced during a hospitalization, and as a result, satisfaction with the use of VR as a method of pain control will be one of the outcomes. Caregivers will simply be asked by the researcher assistant, qualitatively, how satisfied they were with their child's experience with the device, and their comments will be recorded. Collected answers will be divided into positive and negative comments, and any emerging themes will be identified.
Measured: At approximately 48-72 hours postoperatively
Caregiver Satisfaction at 7-10 Days
To assess caregiver satisfaction, qualitative satisfaction will be documented. Patient and caregiver satisfaction and overall experience are commonly linked to pain experienced during a hospitalization, and as a result, satisfaction with the use of VR as a method of pain control will be one of the outcomes. Caregivers will simply be asked by the researcher assistant, qualitatively, how satisfied they were with their child's experience with the device, and their comments will be recorded. Collected answers will be divided into positive and negative comments, and any emerging themes will be identified.
Measured: At approximately 7-10 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start8 Dec 2020
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Specht, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584970
- Sponsor's protocol ID
- 20-0696
- Acronym
- VRAS-PS
- Status last verified
- Jul 2022
- First submitted
- 6 Oct 2020
- Last updated
- 16 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported, after deidentification (text, tables, figures, and appendices), will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to marley.lawrence@unchealth.unc.edu. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years.
Publications
Arane K, Behboudi A, Goldman RD. Virtual reality for pain and anxiety management in children. Can Fam Physician. 2017 Dec;63(12):932-934.
PubMed 29237632Eijlers R, Legerstee JS, Dierckx B, Staals LM, Berghmans J, van der Schroeff MP, Wijnen RM, Utens EM. Development of a Virtual Reality Exposure Tool as Psychological Preparation for Elective Pediatric Day Care Surgery: Methodological Approach for a Randomized Controlled Trial. JMIR Res Protoc. 2017 Sep 11;6(9):e174. doi: 10.2196/resprot.7617.
PubMed 28893727Gold JI, Mahrer NE. Is Virtual Reality Ready for Prime Time in the Medical Space? A Randomized Control Trial of Pediatric Virtual Reality for Acute Procedural Pain Management. J Pediatr Psychol. 2018 Apr 1;43(3):266-275. doi: 10.1093/jpepsy/jsx129.
PubMed 29053848Piskorz J, Czub M. Effectiveness of a virtual reality intervention to minimize pediatric stress and pain intensity during venipuncture. J Spec Pediatr Nurs. 2018 Jan;23(1). doi: 10.1111/jspn.12201. Epub 2017 Nov 20.
PubMed 29155488Ryu JH, Park SJ, Park JW, Kim JW, Yoo HJ, Kim TW, Hong JS, Han SH. Randomized clinical trial of immersive virtual reality tour of the operating theatre in children before anaesthesia. Br J Surg. 2017 Nov;104(12):1628-1633. doi: 10.1002/bjs.10684. Epub 2017 Oct 4.
PubMed 28975600Won AS, Tataru CA, Cojocaru CM, Krane EJ, Bailenson JN, Niswonger S, Golianu B. Two Virtual Reality Pilot Studies for the Treatment of Pediatric CRPS. Pain Med. 2015 Aug;16(8):1644-7. doi: 10.1111/pme.12755. Epub 2015 Apr 30. No abstract available.
PubMed 25930099
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Virtual Reality Intervention After Pediatric Idiopathic Scoliosis Surgery to Reduce Postoperative Pain and Opioid Consumption
- ClinicalTrials.gov ID
- NCT04584970
- Acronym / sponsor ID
- VRAS-PS / 20-0696
- Conditions
- Scoliosis Idiopathic, Pain, Postoperative
- Keywords
- Virtual reality, Distraction methods, Idiopathic scoliosis, Postoperative pain, Pediatric surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Posted 16 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the use of virtual reality after scoliosis surgery in pediatric patients.
Detailed description
Purpose: To evaluate postoperative pain scores and postoperative opioid use in pediatric idiopathic scoliosis surgical patients using virtual reality (VR) as a method of immersive distraction compared with standard electronic use postoperatively.
Participants: Patients age 11-17 undergoing idiopathic scoliosis surgery on Enhanced Recovery After Surgery (ERAS) spine protocol at our institution.
Procedures (methods): Participants will be randomized to intervention arm (VR) or control arm (iPad). Baseline pain and anxiety scores will be assessed. On postoperative day 1, each patient will receive a visit by the research assistant who will assess pain scores, PCA use, etc. The intervention group will be offered a VR device for up to 30 minutes. The control group will be offered an iPad for up to 30 minutes. This visit will be performed twice on postoperative day 1. Follow up survey will be conducted at 48-72 hours and 7-10 days postoperatively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality device | Experimental | Device: Applied VRParticipants will be offered a virtual reality (VR) device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. |
| iPad device | Active comparator | Device: Apple iPadParticipants will be offered an iPad device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Subjects age 11 - 17 years of age
- Patients undergoing idiopathic scoliosis surgery on Enhanced Recovery after Surgery (ERAS) spine protocol (which includes postoperative PCA)
Key exclusion criteria (7 listed)
- Patient/caregiver refusal
- Patients with developmental delay
- Patients with seizure disorder
- Non-English-speaking patients
- Patients with daily opioid use >/= two weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Applied VRThe Applied VR device is a lightweight mobile virtual reality headset with embedded software, creating an immersive experience. The Applied VR is specifically designed for medical use. | Device | Virtual reality device |
| Apple iPadThe Apple iPad is a tablet device controlled by touch screen with a variety of games and applications. | Device | iPad device |
Primary outcome
Pain Scores Via FACES Scale by Patient at Baseline
Time frame: Recorded preoperatively as baseline
All patients will be oriented to the Wong-Baker FACES Pain Rating scale preoperatively. This is a self-assessment scale; patients select a face that illustrates the pain they are experiencing. Scores 0-10, with 0=No hurt and 10=Hurts worst. Higher score indicates a worse outcome.
Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=0
Time frame: Recorded immediately prior to intervention (T=0 min)
All patients will be oriented to the Wong-Baker FACES Pain Rating scale preoperatively. This is a self-assessment scale; patients select a face that illustrates the pain they are experiencing. Scores 0-10, with 0=No hurt and 10=Hurts worst. Higher score indicates a worse outcome. Assessed immediately prior to first intervention exposure (T=0 min) during 1 30-minute session on day 1 postoperatively.
Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=30
Time frame: Recorded at end of intervention (T=30 minutes)
All patients will be oriented to the Wong-Baker FACES Pain Rating scale preoperatively. This is a self-assessment scale; patients select a face that illustrates the pain they are experiencing. Scores 0-10, with 0=No hurt and 10=Hurts worst. Higher score indicates a worse outcome. Assessed immediately after first intervention exposure (T=30 min) following 1 30-minute session on day 1 postoperatively.
Pain Scores Via FLACC Scale by Research Assistant at Baseline
Time frame: Recorded preoperatively as baseline
The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome.
Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=0
Time frame: Recorded immediately prior to intervention (T=0 minutes)
The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome. Assessed immediately prior to first intervention exposure (T=0 min) during 1 30-minute session on day 1 postoperatively.
Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=10
Time frame: Recorded at the 10 minute mark (T=10 minutes)
The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome. Assessed immediately during first intervention exposure (T=10 min) during 1 30-minute session on day 1 postoperatively.
Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=30
Time frame: Recorded at end of intervention (T=30 minutes)
The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome. Participants were allowed to play/interact with intervention for up to 30 minutes. Assessed immediately following first intervention exposure (T=30 min) following 1 30-minute session on day 1 postoperatively.
Opioid PCA Use at T=-60-0
Time frame: Recorded for the hour prior to intervention (T=-60-0 minutes)
Opioid use via Patient-Controlled Analgesia (PCA) pump in mcg or mg as appropriate. PCA use will be converted to morphine equivalents at time of data entry. A higher number indicates more opioid used during the time interval. Higher number indicates a worse outcome.
Opioid PCA Use at T=0-30
Time frame: Recorded during intervention (T=0-30 minutes)
Opioid use via PCA pump in mcg or mg as appropriate. PCA use will be converted to morphine equivalents at time of data entry. A higher number indicates more opioid used during the time interval. Higher number indicates a worse outcome.
Opioid PCA Use at T=30-90
Time frame: Recorded one hour after intervention is complete (T=30-90 minutes)
Opioid use via PCA pump in mcg or mg as appropriate. PCA use will be converted to morphine equivalents at time of data entry. A higher number indicates more opioid used during the time interval. Higher number indicates a worse outcome.
Total Opioid Dose (in Milligram Morphine Equivalents)
Time frame: From anesthesia end through hospital discharge, a total of approximately 2 days
The amount of opioids used by the patient will be recorded in all subjects and converted into milligram morphine equivalents based on chart reviews. This collection method was added to replace PCA pump usage unavailability.
8 secondary outcomes
Electronic Device Use
Time frame: Assessed at time of intervention on postoperative day #1
Baseline Anxiety Score Via STAI Short Form Baseline Anxiety Score Via STAI Short Form
Time frame: Recorded preoperatively as baseline
Postoperative Behavioral Changes Via PHBQ-AS Form at 48-72 Hours
Time frame: At approximately 48-72 hours postoperatively
Postoperative Behavioral Changes Via PHBQ-AS Form at 7-10 Days
Time frame: At approximately 7-10 days postoperatively
Patient Satisfaction at 48-72 Hours
Time frame: At approximately 48-72 hours postoperatively
Patient Satisfaction at 7-10 Days
Time frame: At approximately 7-10 days postoperatively
Caregiver Satisfaction at 48-72 Hours
Time frame: At approximately 48-72 hours postoperatively
Caregiver Satisfaction at 7-10 Days
Time frame: At approximately 7-10 days postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29237632Arane K, Behboudi A, Goldman RD. Virtual reality for pain and anxiety management in children. Can Fam Physician. 2017 Dec;63(12):932-934.
- Background: PubMed 28893727Eijlers R, Legerstee JS, Dierckx B, Staals LM, Berghmans J, van der Schroeff MP, Wijnen RM, Utens EM. Development of a Virtual Reality Exposure Tool as Psychological Preparation for Elective Pediatric Day Care Surgery: Methodological Approach for a Randomized Controlled Trial. JMIR Res Protoc. 2017 Sep 11;6(9):e174. doi: 10.2196/resprot.7617.
- Background: PubMed 29053848Gold JI, Mahrer NE. Is Virtual Reality Ready for Prime Time in the Medical Space? A Randomized Control Trial of Pediatric Virtual Reality for Acute Procedural Pain Management. J Pediatr Psychol. 2018 Apr 1;43(3):266-275. doi: 10.1093/jpepsy/jsx129.
- Background: PubMed 29155488Piskorz J, Czub M. Effectiveness of a virtual reality intervention to minimize pediatric stress and pain intensity during venipuncture. J Spec Pediatr Nurs. 2018 Jan;23(1). doi: 10.1111/jspn.12201. Epub 2017 Nov 20.
- Background: PubMed 28975600Ryu JH, Park SJ, Park JW, Kim JW, Yoo HJ, Kim TW, Hong JS, Han SH. Randomized clinical trial of immersive virtual reality tour of the operating theatre in children before anaesthesia. Br J Surg. 2017 Nov;104(12):1628-1633. doi: 10.1002/bjs.10684. Epub 2017 Oct 4.
- Background: PubMed 25930099Won AS, Tataru CA, Cojocaru CM, Krane EJ, Bailenson JN, Niswonger S, Golianu B. Two Virtual Reality Pilot Studies for the Treatment of Pediatric CRPS. Pain Med. 2015 Aug;16(8):1644-7. doi: 10.1111/pme.12755. Epub 2015 Apr 30. No abstract available.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported, after deidentification (text, tables, figures, and appendices), will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to marley.lawrence@unchealth.unc.edu. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Specht, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Applied VR and Apple iPad in people with Scoliosis Idiopathic and Pain, Postoperative, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores Via FACES Scale by Patient at Baseline (time frame: Recorded preoperatively as baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04584970, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.